K913863 is an FDA 510(k) clearance for the URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125). This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Immunalysis Corporation (Glendale, US). The FDA issued a Cleared decision on September 19, 1991, 23 days after receiving the submission on August 27, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K913863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1991 |
| Decision Date | September 19, 1991 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |